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4.2.3.2 Document and Data Changes


All personnel are required to identify required changes in documents and are encouraged to suggest improvements. Changes to documents and data are reviewed and approved by the same function/organizations that performed the original review and approval, unless specifically designated otherwise. Access to appropriate background information is provided. The nature of the changes is recorded.

When practical, the changes are highlighted in the document and/or on attachments.

4.2.3.3 Obsolete Documents

Electronically maintained documents are promptly removed from active files when they become obsolete. They may be maintained for the document retention period, in file areas not accessible to general users.

After a revision issue, obsolete hard copy documents are promptly removed from points of issue and use. The obsolete master document is archived and may be retained for legal and/or knowledge preservation purposes. The obsolete point of use copy is destroyed.

4.2.4 Control of Quality Records

Quality records are a special case of quality documents. For example, a blank form is a document, a completed form is a record.

A-Vac Industries, Inc. maintains quality records to demonstrate conformance to specified requirements and the effective operation of the Business Management System. Control provides for the identification, collection, indexing, filing, access, storage, maintenance, and disposition of quality records. Pertinent customer or supplier records are an element of these data.

All quality records are legible and are stored and retained in such a manner that they are readily retrievable. Storage facilities provide an environment that minimizes damage, deterioration and prevents loss. Retention times of quality records are established and recorded. A records control matrix is documented to aid control.

5. MANAGEMENT RESPONSIBILITY

5.1 Management Commitment

The top management of A-Vac Industries, Inc. is committed to the development and improvement of an effective Quality Management System. This commitment is demonstrated by:

• Communicating to the organization the importance of meeting all customer, regulatory, and legal requirements. (Section 5.5.3 Internal Communications.)

• Establishing the A-Vac Industries, Inc. Quality Policy for total commitment to excellence and the associated quality objectives. The Quality Policy and the Quality Objectives are published and displayed on the Laboratory network sign-in page and the office notice board. (Sections 5.3 Quality Policy and 5.4.1 Quality Objectives.)

• Conducting Management Reviews. (Section 5.6 Management Review.)

• Identifying and acquisition of controls, processes, equipment, fixtures, resources, and skills need to achieve the required quality. The associated quality management activities are described in Section 6 – Resource Management.

5.2 Customer Focus

Top management of A-Vac Industries, Inc. ensures that customer needs and expectations are determined, converted into requirements, and fulfilled with the aim of meeting or exceeding those expectations. The general needs of our customers are defined by the fact that A-Vac Industries, Inc. was established by the parent company to perform the specific service of metrology. The specific needs of our customers are determined through continual verbal and written communications, as well as periodic visits to their facilities to better understand their individual processes. It is the responsibility of all personnel that interface with customers to access stated or implied needs and bring them to the attention of top management so that they may be addressed. To continually improve, the department also monitors, measures, and analyzes customer satisfaction throughout the business cycle.

The department also meets all of its other obligations including regulatory and legal requirements. This is further described in Section 7.2.1 Determination of Requirements Related to the Equipment.

5.3 Quality Policy

The top management of A-Vac Industries, Inc. has defined and documented its Quality Policy. This policy includes the organization’s commitment for meeting customer requirements and to continual improvement.

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